A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01168414
First received: July 21, 2010
Last updated: July 7, 2011
Last verified: July 2010

July 21, 2010
July 7, 2011
August 2010
January 2011   (final data collection date for primary outcome measure)
Mean intraocular pressure of the 12-hour IOP curve [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav
Same as current
Complete list of historical versions of study NCT01168414 on ClinicalTrials.gov Archive Site
Mean intraocular pressure [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Difference in mean IOP for Ganfort and Duotrav
Same as current
Not Provided
Not Provided
 
A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
A Randomized, Comparison of the Effects of Ganfort and Duotrav on Intraocular Pressure in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Open Label/Evaluator-blind/Cross-over Study

This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ocular Hypertension
  • Primary Open Angle Glaucoma
  • Drug: Ganfort
    Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)
  • Drug: Duotrav
    Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)
  • Active Comparator: Ganfort
    Fixed combination of Bimatoprost and Timolol
    Intervention: Drug: Ganfort
  • Active Comparator: Duotrav
    Fixed combination of Travoprost and Timolol
    Intervention: Drug: Duotrav
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Visual acuity 6/60 or better
  2. Patients who are controlled (IOP < 21 mmHg) on non-fixed combination of Latanoprost & Timolol for at least 3 months before the baseline visit and
  3. Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP>21mmHG)

Exclusion Criteria:

  1. Angle closure glaucoma
  2. Neovascular Galucoma
  3. Secondary open angle glaucoma
  4. Ocular infection/inflammation within 3 months
  5. Ocular surgery within 3 months
  6. History of Refractive surgery
  7. Argon laser trabeculoplasty/Selective laser trabeculoplasty
  8. Pregnancy/nursing
  9. Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution.
  10. Patients in whom beta-blockers are contraindicated
  11. Patients on any drugs known to affect IOP.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT01168414
NMRR-10-466-5929
Not Provided
Dr. Lee Ming Yueh, Ophthalmology Department, Hospital Kuala Lumpur
Ministry of Health, Malaysia
Not Provided
Not Provided
Ministry of Health, Malaysia
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP